Reaction mass of sodium octane-1-sulfonate and disodium octane-1,2-disulfonate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1986-04-02 to 1986-05-10

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

GLP compliance:

no

Type of study:

Buehler test

Justification for non-LLNA method:

This test was performed before the LLNA was adopted as standard method for sensitisation testing.

Test material

Test material information

Constituent 1

Reference substance name:

Sodium octane-1-sulphonate monohydrate

EC Number:

226-195-4

EC Name:

Sodium octane-1-sulphonate monohydrate

Cas Number:

5324-84-5

Molecular formula:

C8H18O3S.Na

IUPAC Name:

sodium octane-1-sulfonate hydrate

Test material form:

liquid

Details on test material:

name of test material in study: BIO TERGE PAS-8S
appearance: clear liquid with cloudy precipitate at the bottom
The test material was received from Stepan Company on March 24, 1986, for use in this test. The sponsor has assumed responsibility for test substance derivation, characterization, and stability testing.

Specific details on test material used for the study:

The material was stored at room temperature in a clear glass bottle throughout the study. The test material was disposed of at the conclusion of testing.

In vivo test system

Test animals

Species:

guinea pig

Strain:

Hartley

Remarks:

Albino

Sex:

male/female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Murphy Breeding Laboratories, Inc.
- Weight at study initiation: 225 to 325 g.
- Housing: Animals were housed singly in wire mesh suspension cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Upon receipt in the laboratory the animals were maintained in quarantine for at least seven days.

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction

Route:

epicutaneous, occlusive

Vehicle:

water

Concentration / amount:

25 % w/v

Day(s)/duration:

3 weekly applications of 6 h

Adequacy of induction:

highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically

Challenge

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

water

Concentration / amount:

5 % w/v

Day(s)/duration:

6 h, two weeks after last induction

Adequacy of challenge:

highest non-irritant concentration

No. of animals per dose:

20

Details on study design:

RANGE FINDING TESTS:
Primary Irritation
Prior to induction and primary challenge, the test material was applied to guinea pigs to determine the concentrations appropriate for use during these study phases. For this purpose, BIO TERGE PAS-8S was tested undiluted and as 50 %, 25 %, 10 %, 5 %, 2.5 %, and 1.0 % w/v formulations in distilled water.
On the day before the applications were made, the backs of the animals were clipped with electric clippers to provide enough area to test four concentrations on each guinea pig. On the following day, the animals were placed in stainless steel restrainers and patches were applied to each animal. The patches, incorporating a 25 mm Hill Top Chamber, were moistened with 0.3 ml of one of the test formulations. The patches were occluded with dental dam placed over the back of each animal and secured with metal clips. The animals were restrained for six hours and then returned to their cages.
On the day following applications, the clipped areas were depilated with NEET CREAM HAIR REMOVER (Whitehall Laboratories, Inc.). The depilatory was allowed to remain on the sites for seven to nine minutes and then washed off with warm tap water. The patch sites were scored for severity of response at 24-hours and 48-hours without additional depilation. A concentration of 25 % w/v in distilled water was chosen for use at induction while a concentration of 5 % w/v in distilled water was chosen for use at primary challenge.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 3 weeks
- Test groups: 1 group of 20 animals
- Control group: none
- Site: upper left quadrant of the back
- Frequency of applications: once per week
- Duration: 6 h
- Concentrations: 25 %w/v

B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 1 week
- Exposure period: 6 h
- Test groups: 1 group of 20 animals
- Control group: yes, 10 animals
- Site: lower left quadrant of the back
- Concentrations: 5 % w/v
- Evaluation (hr after challenge): 24 h and 48 h

Challenge controls:

yes

Positive control substance(s):

no

Results and discussion

Positive control results:

no positive control

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

5 % w/v

No. with + reactions:

5

Total no. in group:

19

Clinical observations:

not specified

Remarks on result:

other: contradictory information on challenge concentration in report (reported as 5 %w/v and 10 % w/v)

Results 2

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

5 % w/v

No. with + reactions:

5

Total no. in group:

19

Clinical observations:

not specified

Remarks on result:

other: contradictory information on challenge concentration in report (reported as 5 %w/v and 10 % w/v)

Results 3

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

5 % w/v

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

not specified

Remarks on result:

other: contradictory information on challenge concentration in report (reported as 5 %w/v and 10 % w/v)

Results 4

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Dose level:

5 % w/v

No. with + reactions:

3

Total no. in group:

10

Clinical observations:

not specified

Remarks on result:

other: contradictory information on challenge concentration in report (reported as 5 %w/v and 10 % w/v)

Results 5

Group:

positive control

Remarks on result:

not measured/tested

Any other information on results incl. tables

Table 1: Skin grades following primary challenge of the test item in guinea pigs

Animal No.	Sex	Numerical Score
		24-hour	48-hour
Test Material (10 % w/v in distilled water) in Induced Animals
T-1 YL327	M	0	0
T-2 YL327	M	0	0
T-3 YL327	M	0	0
T-4 YL327	M	0	0
T-5 YL327	M	0	0
T-6YL327	M	0	0
T-7 YL327	M	0	±
T-8 YL327	M	0	0
T-9YL327	M	0	0
T-10YL327	M	0	±
T-11YL327	F	0	0
T-12YL327	F	0	0
T-13YL327	F	0	0
T-14YL327	F	0	±
T-15YL327	F	±	±
T-16YL327	F	0	0
T-17 YL327	F	0	0
T-18 YL327	F	0	0
T-19YL327	F	FD	FD
T-20 YL327	F	0	±
		Mean 0.03	Mean 0.1
Test Material (10 % w/v in distilled water) in Naive Animals
C-21YL327	M	0	0
C-22 YL327	M	0	0
C-23 YL327	M	0	0
C-24YL327	M	0	±
C-25 YL327	M	0	0
C-26YL327	F	0	±
C-27 YL327	F	0	0
C-28 YL327	F	0	0
C-29YL327	F	0	±
C-30YL327	F	0	0
		Mean 0.0	Mean 0.2

±=slight patchy erythema (Grades of + are equal to 0.5 for calculating the mean)

FD = Animal found dead following third induction. Necropsy showed lungs pale, liver pale, abdominal cavity filled with a red blood-like material, and slight post-mortem autolysis.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The potential of sodium octane-1-sulphonate monohydrate (EC 226-195-4; CAS 5324-84-5) as a 25 % w/v formulation in distilled water to produce a delayed contact hypersensitivity response in guinea pigs was evaluated in a modification of the Buehler test.
The incidence of grade + responses in the test group (5 of 19) was compared to that of the naive control group, (3 of 10) at primary challenge. The incidence and severity of the responses in the test group was essentially comparable to that produced by the naive control group indicating that sensitisation had not been induced.

Executive summary:

The potential of sodium octane-1-sulphonate monohydrate (EC 226-195-4; CAS 5324-84-5) to produce delayed contact hypersensitivity in guinea pigs was evaluated by a modification of the Buehler test. The test material, as a 25 % w/v formulation in distilled water, was applied to the backs of male and female Hartley guinea pigs for three six-hour periods at weekly intervals. Group sizes were 20 animals for the test group and 10 animals for the naive control group. Approximately two weeks after the last induction session, the test material prepared as a 5 % w/v formulation in distilled water was reapplied to the test animals for six hours. The test material was also applied to ten naive control animals. The next day the sites were depilated and scored for severity of response 24-hours and 48-hours after removal of the patches. The incidence of grade + responses in the test group (5 of 19) was compared to that of the naive control group, (3 of 10) at primary challenge. The incidence and severity of the responses in the test group was essentially comparable to that produced by the naive control group indicating that sensitisation had not been induced.